Health Law and Policy Commons^™

Health Information Ownership: Legal Theories And Policy Implications, Lara Cartwright Smith, Elizabeth Gray, Jane H. Thorpe

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the nature and characteristics of health information that make it subject to federal and state laws and the existing legal framework that confers rights and responsibilities with respect to health information. There are numerous legal and policy considerations surrounding the question of who owns health information, including whether and how to confer specific ownership rights to health information. Ultimately, a legal framework is needed that reflects the rights of a broad group of stakeholders in the health information marketplace, from patients to providers to payers, as well as the public's interest in appropriate sharing of health information.

Reference-Dependence Effects In Benefit Assessment: Beyond The Wta-Wtp Dichotomy And Wta-Wtp Ratios, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Willingness-to-pay (WTP) values and willingness-to-accept (WTA) values have received considerable attention, but the role of reference-dependence effects is more diverse. Policies involving cost and risk may have reference point effects with respect to both cost and risk, leading to four potential valuation measures. Experimental evidence for water quality policies suggests that the cost reference effects are particularly influential in that context. There is, however, no evidence of significant reference effects for labor market estimates of the value of a statistical life. Sound application of benefit values other than WTP measures requires pertinent empirical evidence and an assessment of the underlying …

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

Contextualizing Gay‐Straight Alliances: Student, Advisor And Structural Factors Related To Positive Youth Development Among Members, Matthew P. Shaw

Vanderbilt Law School Faculty Publications

Gay-straight alliances (GSAs) may promote resilience. Yet, what GSA components predict well-being? Among 146 youth and advisors in 13 GSAs (58% lesbian, gay, bisexual, or questioning; 64% White; 38% received free/reduced-cost lunch), student (demographics, victimization, attendance frequency, leadership, support, control), advisor (years served, training, control), and contextual factors (overall support or advocacy, outside support for the GSA) that predicted purpose, mastery, and self-esteem were tested. In multilevel models, GSA support predicted all outcomes. Racial/ethnic minority youth reported greater well-being, yet lower support. Youth in GSAs whose advisors served longer and perceived more control and were in more supportive school contexts …

Confronting Legal And Technological Incongruity: Remote Testimony For Child Witnesses, Elizabeth A. Mulkey

Vanderbilt Journal of Entertainment & Technology Law

Child victims are often the only eyewitnesses in cases against their abusers. A child's testimony may be necessary for a prosecutor to secure a conviction. However, the child must often face his or her abuser and relive the traumatic experience while giving this testimony. Any accommodations or protection of a child witness at trial must be balanced against the defendant's rights under the Confrontation Clause. The Supreme Court's decision in Maryland v. Craig allows child victims to testify via one-way, closed-circuit television in some circumstances, but the Court has not addressed two-way, closed-circuit testimony or remote testimony. In the absence …

Professional Standards And Legal Standard Setting, Kirsten N. Bookmiller

Vanderbilt Journal of Transnational Law

This Article draws attention to the nascent efforts of emergency medical personnel, convened under World Health Organization auspices, to improve humanitarian health responses following catastrophic natural disasters. The Foreign Medical Team Working Group (FMT-WG) is pursuing new professional standards related to sectoral coordination, classification and registration. As its approach has been significantly influenced by the International Search and Rescue Advisory Group's (INSARAG) prior advances in these areas, INSARAG's contributions will first be highlighted. While more atypical contributors to international lawmaking than traditionally studied, the efforts by both groups shed significant light into the burgeoning International Disaster Response Law field. Two …

Kickbacks And Contradictions: The Anti-Kickback Statute And Electronic Health Records, Daniel E. Rheiner

Vanderbilt Journal of Entertainment & Technology Law

The Obama Administration has made the universal adoption of electronic health records a major policy priority, passing the Health Information Technology for Economic and Clinical Health (HITECH) Act, which creates incentives for physicians and hospitals to computerize their medical records. This effort has been largely successful, as evidenced by the significant increase in medical providers who have adopted electronic health records. However, for the President to achieve his goal of computerizing all medical records in the United States, he will need to ensure that other federal laws do not conflict with the incentive structure created by the HITECH Act. The …

Addressing The Ethical Challenges In Genetic Testing And Sequencing Of Children, Ellen Wright Clayton, Laurence B. Mccullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf

Vanderbilt Law School Faculty Publications

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recom-mendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium’s PediatricsWorking Group compared these recommendations, focusing on operational and ethical issues specific to decision making forchildren. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locusof decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or come to different butcompatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways.AAP/ACMG analyzes risks and benefits …

Changing The Costs: A Rational Choice Perspective On African Americans' Healthcare Consumption Decisions, Nicole Langston

Vanderbilt Law School Faculty Publications

This paper makes the case for racial disparities in the consumption of healthcare and advocates for a large-scale cost-benefit change for healthcare practitioners and the African American community to ensure efficient consumption of healthcare by African American patients. Part I explores the history of African Americans and the healthcare system, arguing the history of this interaction fuels many of the present-day decisions not to consume healthcare.

Part II explores the current racial differences in healthcare treatment and outcomes for African Americans in order to lay the framework for racially disparate treatment in America's healthcare system.

Part III of this paper …

Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad

Vanderbilt Law School Faculty Publications

Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care …

Recommendations For Returning Genomic Incidental Findings? We Need To Talk!, Ellen Wright Clayton, Wylie Burke, Armand H. Matheny Antommaria, Et Al.

Vanderbilt Law School Faculty Publications

The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated …

A Gap In The Affordable Care Act: Will Tax Credits Be Available For Insurance Purchased Through Federal Exchanges?, Amy E. Sanders

Vanderbilt Law Review

Millions of Americans rest assured that the Patient Protection and Affordable Care Act' ("ACA") provides tax credits for health insurance to individuals earning 100-400% of the federal poverty line. The tax credits will be accessible through state insurance exchanges, also known as Marketplaces, which are government- regulated organizations designed to create more competition in the health insurance industry. But a gap in the unwieldy, two-thousand- plus-page statute-either a scrivener's error or an overlooked loophole-is raising questions about whether citizens in certain states are eligible for the tax credits. This "quirk" could be a serious blow to an already contentious healthcare-reform …

The Benefits Of Mortality Risk Reduction: Happiness Surveys Vs. The Value Of A Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

A principal component of many benefit-cost analyses (BCAs) of health, safety, and environmental regulations is the valuation of the fatality risk effects of the underlying policy. Government agencies currently value these expected effects using estimates of the value of a statistical life (VSL), that is, the tradeoff rate between money and very small risks of death. This measure corresponds to BCA's theoretically appropriate benefits measure, which is society's willingness to pay for the risk reduction. Here, I will review the VSL approach, compare it to suggested alternatives that use happiness measures of well-being, and address some of the misunderstandings that …

Patient Awareness And Approval For An Opt-Out Genomic Biorepository, Ellen Wright Clayton, Kyle B. Brothers, Matthew J. Westbrook, M. Francis Wright, John A. Myers, Daniel R. Morrison, Jennifer L. Madison, Jill M. Pulley

Vanderbilt Law School Faculty Publications

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository. Materials & methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA). Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%. Conclusion: These …

Late Fathers' Later Children: Reconceiving The Limits Of Survivor's Benefits In Response To Death-Defying Reproductive Technology, Jeffrey W. Sheehan

Vanderbilt Journal of Entertainment & Technology Law

When Congress instructed the Social Security Administration to begin paying a social insurance benefit to "widows and orphans" in the 1930s, it simplified the process of determining an applicant's relationship to an insured decedent in two significant ways: First, Congress ordered the agency to honor the intestate laws of each state when determining whether an applicant was actually the child of a decedent, and second, it ordered the agency to treat any child who could qualify as an intestate heir as if that child actually depended on the parent financially at the time of the parent's death. Three-quarters of a …

What’S To Know? Puzzles In The Literature On The Value Of Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Notwithstanding the general acceptance of the value of statistical life (VSL) estimates for policy assessment purposes, several important unresolved issues remain. First, the results from revealed preference studies are systematically higher than those from stated preference studies, potentially limiting the usefulness of stated preference studies in generalizing the VSL estimates to different populations and kinds of risks. Second, extrapolating the results of meta-analyses to project the VSL for different population groups requires that such generalization be reflective of the underlying economic content of what average VSL estimates reflect. Third, government agencies within and across countries place differing emphasis on types …

Dynamics Of Healthcare Reform: Bitter Pills Old And New, Christopher N.J. Roberts

Vanderbilt Journal of Transnational Law

The United States is at a crossroads--albeit one it has visited several times before. Although the Supreme Court has ruled upon the constitutionality of the Patient Protection and Affordable Care Act, the polarizing controversy surrounding national healthcare that began several generations ago is likely to continue into the foreseeable future. In this latest round of national debates, the issue of healthcare has been framed exclusively as a domestic issue. But history shows that the question of national healthcare in the United States has also been an extremely important issue for international law and international politics. To shed light on the …

"Sell's" Conundrums: The Right Of Incompetent Defendants To Refuse Anti-Psychotic Medication, Christopher Slobogin

Vanderbilt Law School Faculty Publications

The Supreme Court's 2003 decision in Sell v. United States declared that situations in which the state is authorized to forcibly medicate a criminal defendant to restore competency to stand trial "may be rare." Experience since Sell indicates that this prediction was wrong. In fact, wittingly or not, Sell created three exceptions to its holding (the dangerousness, treatment incompetency, and serious crime exceptions) that virtually swallow the right to refuse. Using the still-on-going case of Jared Loughner as an illustration, this essay explores the scope of these exceptions and the dispositions available in those rare circumstances when none of them …

An Investigation Of The Rationality Of Consumer Valuations Of Multiple Health Risks, W. Kip Viscusi, Wesley A. Magat, Joel Huber

Vanderbilt Law School Faculty Publications

After developing a conceptual analysis of consumer valuation of multiple risks, we explore both economic and cognitive hypotheses regarding individual risk-taking. Using a sample of over 1,500 consumers, our study ascertains risk-dollar tradeoffs for the risks associated with using an insecticide and a toilet bowl cleaner. We observe the expected positive valuation of risk reductions andfind empirical supportfor a diminishing in the valuation of risk reduction as the extent of the risk reduction increases. We also find evidence of certainty premiums for the total elimination of one risk, but no strong evidence of additional certainty premiums for the elimination of …

Heterogeneous Rates Of Time Preference And The Decision To Smok, W. Kip Viscusi, Robert L. Scharff

Vanderbilt Law School Faculty Publications

Individuals with higher personal rates of time preference will be more likely to smoke. Although previous studies have found no evidence of a relationship between smoking and rates of time preference, analysis of implicit rates of time preference associated with workers' wage fatality risk trade-offs indicates that smokers have higher rates of time preference with respect to years of life. Current smokers have an implied rate of time preference of 13.8% as compared to 8.1% for nonsmokers. Current smokers who are blue-collar workers have rates of time preference with respect to years of life of 16.3% compared to 7.8% for …

Intended And Unintended Consequences Of Youth Bicycle Helmet Laws, Christopher (Kitt) Carpenter, Mark Stehr

Vanderbilt Law School Faculty Publications

More than 20 states have adopted laws requiring youths to wear a helmet when riding a bicycle. We confirm previous research indicating that these laws reduced fatalities and increased helmet use, but we also show that the laws significantly reduced youth bicycling. We find this result in standard two-way fixed-effects models of parental reports of youth bicycling and in triple-difference models of self-reported bicycling among high school youths that explicitly account for bicycling by youths just above the age threshold of the helmet law. Our results highlight important intended and unintended consequences of a well-intentioned public policy.

Causing Infringement, Mark Bartholomew, Patrick F. Mcardle

Vanderbilt Law Review

In its most recent contributory infringement pronouncement, the Supreme Court advised courts wrestling with these issues to consult tort law's own contributory liability framework, which it described as "well established."31 The conventional wisdom among legal scholars agrees with the Court. Most scholarship in this area contends that obeisance to traditional tort law principles of contributory liability will fill the void in infringement law with answers that are adequately calibrated to the balance between incentivizing creation and permitting downstream use. This Article challenges that conventional wisdom. Although we agree that tort law can shed some much-needed light on contributory infringement, we …

Ambivalence And Activism: Employment Discrimination In China, Timothy Webster

Vanderbilt Journal of Transnational Law

Chinese courts have not vigorously enforced many human rights, but a recent string of employment discrimination lawsuits suggests that, given the appropriate conditions, advocacy strategies, and rights at issue, victims can vindicate constitutional and statutory rights to equality in court. Specifically, carriers of the hepatitis B virus (HBV) have used the 2007 Employment Promotion Law to ground legal challenges against employers who discriminate against them in the hiring process. Plaintiffs' relatively high success rate suggests official support for making one prevalent form of discrimination illegal. Central to these lawsuits is a broad network of lawyers, activists, and scholars who actively …

Smoking Restrictions In Bars And Bartender Smoking In The Us, Christopher (Kitt) Carpenter, Marianne P. Bitler, Madeline Zavodny

Vanderbilt Law School Faculty Publications

Objective The present work is an analysis of whether adoption of state clean indoor air laws (SCIALs) covering bars reduces the proportion of bartenders who smoke primarily by reducing smoking among people already employed as bartenders when restrictions are adopted or by changing the composition of the bartender workforce with respect to smoking behaviours.

Methods Logistic regressions were estimated for a variety of smoking outcomes, controlling for individual demographic characteristics, state economic characteristics, and state, year, and month fixed effects, using data on 1380 bartenders from the 1992–2007 Tobacco Use Supplement to the Current Population Survey combined with data on …

Electronic Medical Records: A Prescription For Increased Medical Malpractice Liability?, Blake Carter

Vanderbilt Journal of Entertainment & Technology Law

The cost and quality of health care is and most likely will continue to be one of the most important issues that the United States faces in the coming decade. Although no powerful antidote exists to cure this industry of all of its ailments, one potential suggestion to treat some of the symptoms is the introduction of electronic medical records (EMRs).

Members of the medical community, patients, and even politicians all agree that EMRs offer promising opportunities to improve the overall quality of health care. However, lost in the discussion of these opportunities, is a consideration of the potential side …

There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland

Vanderbilt Journal of Entertainment & Technology Law

Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …

The Right To Voice Reprised, Christopher Slobogin

Vanderbilt Law School Faculty Publications

This article appears in a symposium issue of Seton Hall Law Review on courtroom epistemology. In Proving the Unprovable: The Role of Law, Science and Speculation in Adjudicating Culpability and Dangerousness, I argued that criminal defendants ought to be able to present speculative psychiatric testimony if the expert has followed a routinized evaluation process that addresses the relevant legal criterion, an argument based in part on the position that the Constitution can be read to entitle defendants to tell their exculpatory mental state stories. In a recent essay, Professor Lillquist takes aim at this latter rationale, which I called the …

Policy Challenges Of The Heterogeneity Of The Value Of Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Economic research has developed estimates of the heterogeneity of the value of statistical life (VSL) on dimensions such as individual age, income, immigrant status, and the nature of the risk exposure. This paper examines the empirical evidence on the heterogeneity of VSL and explores the potential implications for the valuation of regulatory policies. Previously, the U.S. Environmental Protection Agency (EPA) unsuccessfully sought to adopt a simple age discount percentage for VSL based on survey evidence. However, labor market estimates of VSL indicate a pattern that tracks lifetime consumption trajectories, as the VSL rises with age and eventually tapers off but …

Big Tobacco, Medicaid-Covered Smokers, And The Substance Of The Master Settlement Agreement, Gregory W. Traylor

Vanderbilt Law Review

In 1994, executives from "Big Tobacco"-industry leaders Philip Morris, R.J. Reynolds, Brown and Williamson Tobacco, and Lorillard-appeared before Congress and denied that nicotine is addictive despite internal documents disclosing a long history of industry-wide awareness about the addictive nature of the drug. One executive even denied that smoking causes death despite the well- established scientific consensus to the contrary. Worse still, tobacco companies had consciously targeted children as young as fourteen-years-old in their advertising schemes. In an internal R.J. Reynolds memorandum to Vice President of Marketing C.A. Tucker, J.F. Hind wrote: "To ensure increased and longer-term growth for CAMEL FILTER, …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …